Neurofeedback for Treatment of Central Neuropathic Pain (CNP) in Sub-acute Spinal Cord Injury (SCI)

Sponsor

NHS Greater Glasgow and Clyde (Other)

Overall Status

Completed

CT.gov ID

NCT02178917

Collaborator

University of Glasgow (Other)

Enrollment

Location

Arms

39.1

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in the body. SCI is also an indirect cause of a persistent pain, called Central Neuropathic Pain (CNP). This pain typically develops several months after the injury. In 30-40% of SCI patients, severe CNP affects their everyday living including sleep and mood. Many patients give up work, not because of the injury, but because of pain. Medical treatment of CNP is moderately effective and costly, both to the patient and to the health care system.

In previous research, characteristic 'signatures' of brain waves that are probably related to CNP have been defined. Based on this, a novel treatment for CNP based on neurofeedback was developed and clinically tested on five SCI patients. Electroencephalograph (EEG) was used to record patients' brain waves and these were shown to patients on a computer screen in a simple graphical form (e.g. bars). Patients were trained to change their brain activity at will and, as a consequence, their pain was reduced. Patients who had suffered from CNP for years received up to 40 neurofeedback treatment sessions, reducing their pain for several days after each session.

The primary aim of this study is to apply neurofeedback therapy to a larger number of recently injured patients, who are still in a hospital. It is hypothesised that neurofeedback treatment will be more effective in people who have suffered from CNP for a shorter period of time.

The secondary aim of the study is to define EEG predictors of CNP. EEG will be recorded in recently injured patients with no chronic pain, knowing that a certain number of patients will develop CNP within weeks or months. These patients will be followed up for a year and the EEGs of patients who develop CNP will be compared with those who do not.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury	Other: Neurofeedback therapy Other: No neurofeedback therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Neurofeedback Treatment of Central Neuropathic Pain (CNP) in Sub-acute Patients With Spinal Cord Injury (SCI)

Actual Study Start Date :

Aug 27, 2014

Actual Primary Completion Date :

Nov 29, 2017

Actual Study Completion Date :

Nov 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patients with central neuropathic pain Randomised to 20 neurofeedback therapy sessions	Other: Neurofeedback therapy
Other: Control: patients with central neuropathic pain Randomised to no neurofeedback treatment	Other: No neurofeedback therapy
No Intervention: patients with no central neuropathic pain Observed for development of central neuropathic pain

Arm

Intervention/Treatment

Experimental: patients with central neuropathic pain

Randomised to 20 neurofeedback therapy sessions

Other: Neurofeedback therapy

Other: Control: patients with central neuropathic pain

Randomised to no neurofeedback treatment

Other: No neurofeedback therapy

No Intervention: patients with no central neuropathic pain

Observed for development of central neuropathic pain

Outcome Measures

Primary Outcome Measures

Intensity of Pain [1 year]
As measured by a numerical analogue scale

Secondary Outcome Measures

Changes in EEG activity [1 year]
Changes in Spasticity [1 year]
Modified Ashworth Scale and patellar reflex
Changes in Mood [1 year]
Changes in quality of sleep [1 year]
Medical Outcomes Study (MOS) Sleep Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with Central Neuropathic Pain (Treatment and Control Groups)

Normal or corrected to normal vision
No history of brain disease or injury
Incomplete/complete spinal cord injury at level C5 to T12
Below level neuropathic pain for at least 6 weeks
Intensity of pain 4 or above (verbal numeric scale - VNS)
Stable medication regime responding to some extent to CNP medication treatment

Patients with no chronic pain

Normal or corrected to normal vision
No history of brain disease or injury
Incomplete/complete injury at level C5 to T12
Within 23 months post-injury

Exclusion Criteria:

Patients with Central Neuropathic Pain (Control and Treatment Groups)

Chronic or acute muscular or visceral pain larger than 4 VNS.
Epilepsy
Diagnosed mental health problems
Active intervention of pain team

Patients with no chronic pain

Chronic or acute pain larger than 3 on the VNS.
Epilepsy
Diagnosed mental health problems

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Elizabeth National Spinal Injuries Unit, Southern General Hospital	Glasgow		United Kingdom	G51 4TF

Sponsors and Collaborators

NHS Greater Glasgow and Clyde
University of Glasgow

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NHS Greater Glasgow and Clyde

ClinicalTrials.gov Identifier:

NCT02178917

Other Study ID Numbers:

GN14NE311

First Posted:

Jul 1, 2014

Last Update Posted:

Mar 1, 2019

Last Verified:

Feb 1, 2019

Additional relevant MeSH terms:

Spinal Cord Injuries

Neuralgia

Wounds and Injuries

Study Results

No Results Posted as of Mar 1, 2019